Senior Manager, Quality Control

Role Summary

Senior Manager, Quality Control responsible for quality oversight of analytical methods and specifications used to test and release Acadia’s products. Oversees analytical method development, transfer, validation, and release at contract service providers (CSPs); reviews release and stability data for drug substances (DS) and drug products (DP); coordinates reporting and trend analysis with CSPs and prepares data for regulatory submissions. Location: San Diego, CA. Hybrid role requiring in-office presence three days per week on average.

Responsibilities

• Review and evaluate analytical test results for DS and DP
• Review and author analytical method protocols and validations for commercialized products
• Review and author analytical transfer protocols and reports between laboratories
• Author stability protocols and reports, including trending analysis of all data
• Negotiate and/or review stability related agreements
• Author and review analytical data summaries to support batch release and stability assessments
• Assist in the review of reports for regulatory filings
• Interact with CSPs to facilitate stability testing at contract laboratories for Acadia projects
• Coordinate stability studies including reporting of test results
• Familiar with extractable and leachable testing, container closure and packaging qualification and integrity testing, and cleaning verification method development and validation
• Conduct and document analytical deviations, out-of-specification (OOS), out-of-trend (OOT) investigations, and CAPA reports following SOPs and GMP guidelines
• Maintain training records per GMP training requirements
• Ability to maintain effectiveness in a changing environment
• Set high standards and assume responsibility for scheduling and successfully completing assignments and tasks as required by company timelines
• Interact and collaborate effectively with staff and CSPs
• Assist with data review at CSPs
• Assist with routine GMP audits of CSPs

Qualifications

• Required: BA/BS in chemistry or biochemistry with 8 years of experience in a pharmaceutical company environment
• Demonstrated proficiency in analytical science by experience and/or education
• Preferred: Experience in the review of DS and DP release and stability data
• Preferred: Experience with stability, method development, validation and transfer related to the testing of DS and DP
• Preferred: Experience working in a GMP environment, Quality Control and/or Quality Assurance
• Preferred: Experience with the documentation of deviations and investigations in a GMP, quality controlled system
• Required: Contract service provider experience
• Must possess: Analytical Chemistry Manufacturing Controls (CMC) experience
• Must possess: Knowledge of current Good Manufacturing Practices (GMPs)
• Must possess: Experience in analytical development, validation and testing
• Must possess: Knowledge of laboratory instruments (e.g., HPLC, GC, KF, IR)
• Must possess: Statistical modeling experience
• Must possess: Well organized
• Must possess: Excellent written/oral communication skills

Education

• BA/BS in chemistry or biochemistry (required)

Skills

• Excellent written and verbal communication and interpersonal skills
• Excellent organizational skills, detail-oriented, self-starter, able to multitask
• Ability to negotiate and interact constructively with others
• Contract service provider experience
• Knowledge of current Good Manufacturing Practice (GMPs)
• Experience in analytical development, validation and testing
• Knowledge of laboratory instruments (e.g., HPLC, GC, KF, IR)
• Statistical modeling experience

Additional Requirements

• Travel: Ability to travel 20% of time domestically and internationally
• Physical demands: Regular standing, walking, sitting, and use of hands for handling or operating equipment; ability to reach, climb, balance, stoop, kneel, crouch; occasional lifting up to 20 pounds; ability to travel overnight and/or work after hours as required